Featured Research

from universities, journals, and other organizations

Recommendation for use of heart failure treatment formulated

Date:
March 19, 2010
Source:
University of Rochester Medical Center
Summary:
The FDA's Circulatory System Devices Panel recommended that the cardiac resynchronization therapy defibrillator (CRT--D), developed by Boston Scientific, be approved for use in patients with mild heart failure in the United States. If the device is approved by the FDA, nearly 4 million more Americans could be candidates for treatment with the CRT-D.

Cardiac resynchronization therapy defibrillator.
Credit: Image courtesy of University of Rochester Medical Center

A new therapy that reduces the risk of mortality and heart failure in patients with mild cardiac disease received a thumb's up this week from an advisory panel to the U.S. Food and Drug Administration. The panel recommended that the cardiac resynchronization therapy defibrillator (CRT-D), tested extensively nationwide under the leadership of cardiologist Arthur Moss, M.D., professor of Medicine at the University of Rochester Medical Center, be approved for use in patients with mild heart failure in the United States.

Related Articles


The device under review was developed by Boston Scientific and is already approved to treat patients with severe heart failure. With device approval by the FDA, nearly 4 million more Americans could be candidates for treatment with the CRT-D. The recommendations by its panels are often, but not always, followed by the FDA.

In the major study which tested the device -- the MADIT-CRT trial -- patients who had a cardiac resynchronization device combined with a defibrillator (CRT-D) implanted had a 34 percent reduction in their risk of death or heart failure compared to patients receiving only an implantable cardioverter defibrillator (ICD). Heart failure alone was reduced by 41 percent in all patients, with a remarkable 63 percent reduction of heart failure in women. The study results were published last year in the New England Journal of Medicine.

This week, Moss presented clinical data from the MADIT-CRT study at a meeting of the FDA's Circulatory System Devices panel showing that the combination of an implanted cardiac defibrillator, which detects irregular and potentially fatal heart rhythms and shocks the heart back into a normal rhythm, with cardiac resynchronization therapy, which improves the mechanical pumping action of the heart, provides preventive benefit to patients with more mild cardiac disease.

"The panel's recommended approval of this therapy is great news for a large population of patients in which it could effectively prevent heart failure progression," said Moss. "The ultimate goal of this new therapy is to not only help patients live longer, but to help them live better."

The new device combines two functions found in current devices: an ICD, which is designed to prevent sudden cardiac death, and cardiac resynchronization therapy, which works to reduce heart failure and associated symptoms.

About 70 percent of the approximately 5.5 million Americans with some form of heart failure, or 3.9 million people, have milder forms of heart failure known as "Class I" or "Class II," the forms considered by the FDA in its decision this week.

The MADIT-CRT study followed 1,820 patients from 110 medical centers in the United States, Canada and Europe for four-and-one-half years. The trial was sponsored by Boston Scientific through a research grant to the University of Rochester. The study is the world's largest randomized trial involving Class I and Class II heart failure patients.

Prior to MADIT-CRT, Moss and his colleagues at the University of Rochester directed MADIT-I and MADIT-II, which evaluated the safety and efficacy of ICDs in high-risk heart failure patients. These trials set the stage for MADIT-CRT and the evaluation of defibrillators with resynchronization therapy in lower-risk patients.


Story Source:

The above story is based on materials provided by University of Rochester Medical Center. Note: Materials may be edited for content and length.


Cite This Page:

University of Rochester Medical Center. "Recommendation for use of heart failure treatment formulated." ScienceDaily. ScienceDaily, 19 March 2010. <www.sciencedaily.com/releases/2010/03/100319142702.htm>.
University of Rochester Medical Center. (2010, March 19). Recommendation for use of heart failure treatment formulated. ScienceDaily. Retrieved March 27, 2015 from www.sciencedaily.com/releases/2010/03/100319142702.htm
University of Rochester Medical Center. "Recommendation for use of heart failure treatment formulated." ScienceDaily. www.sciencedaily.com/releases/2010/03/100319142702.htm (accessed March 27, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Friday, March 27, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

House Ready to Pass Medicare Doc Bill

House Ready to Pass Medicare Doc Bill

AP (Mar. 26, 2015) — In rare bipartisan harmony, congressional leaders pushed a $214 billion bill permanently blocking physician Medicare cuts toward House passage Thursday, moving lawmakers closer to resolving a problem that has plagued them for years. (March 26) Video provided by AP
Powered by NewsLook.com
What's Different About This Latest Ebola Vaccine

What's Different About This Latest Ebola Vaccine

Newsy (Mar. 26, 2015) — A whole virus Ebola vaccine has been shown to protect monkeys exposed to the virus. Here&apos;s what&apos;s different about this vaccine. Video provided by Newsy
Powered by NewsLook.com
HIV Outbreak Prompts Public Health Emergency In Indiana

HIV Outbreak Prompts Public Health Emergency In Indiana

Newsy (Mar. 26, 2015) — Indiana Gov. Mike Pence says he will bring additional state resources to help stop the epidemic. Video provided by Newsy
Powered by NewsLook.com
Indiana Permits Needle Exchange as HIV Cases Skyrocket

Indiana Permits Needle Exchange as HIV Cases Skyrocket

Reuters - US Online Video (Mar. 26, 2015) — Governor Mike Pence declares the recent HIV outbreak in rural Indiana a "public health emergency" and authorizes a short-term needle-exchange program. Rough Cut (no reporter narration) Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins